DeLLphi-304
Trial question
What is the effect of tarlatamab in patients with small cell lung cancer that progressed during or after platinum-based chemotherapy?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
31.0% female
69.0% male
N = 509
509 patients (158 female, 351 male).
Inclusion criteria: adult patients with small cell lung cancer that progressed during or after platinum-based chemotherapy.
Key exclusion criteria: symptomatic CNS metastases; leptomeningeal disease; prior history of immune checkpoint inhibitors resulting in adverseevents; active autoimmune disease that has required systemic treatment within the past 2 years or any other diseases requiring immunosuppressive therapy; solid organ transplantation; MI and/or symptomatic congestive HF in the past 12 months.
Interventions
N=254 tarlatamab (intravenous infusion at a dose of 1 mg on day 1 of cycle 1, followed by 10 mg on days 8 and 15 of cycle 1 and then 10 mg every 2 weeks thereafter in 28-day cycles).
N=255 chemotherapy (topotecan, lurbinectedin, or amrubicin for 21-day cycles).
Primary outcome
Median overall survival
13.6 months
8.3 months
13.6 months
10.2 months
6.8 months
3.4 months
0.0 months
Tarlatamab
Chemotherapy
Significant
increase ▲
Significant increase in median overall survival (13.6 months vs. 8.3 months; HR 1.67, 95% CI 1.3 to 2.13).
Secondary outcomes
Significant increase in progression-free survival at 12 months (5.3 months vs. 4.3 months; HR 1.41, 95% CI 1.16 to 1.69).
Significant increase in confirmed objective response rate (35% vs. 20%; RR 1.73, 95% CI 1.29 to 2.33).
Significantly greater reduction in mean dyspnea score after 18 weeks (1.94 points vs. -7.2 points; MD 9.14, 95% CI 5.64 to 12.64).
Safety outcomes
No significant difference in adverse and serious events.
Significant difference in ≥ 3 grade adverse events (54% vs. 80%).
Conclusion
In adult patients with small cell lung cancer that progressed during or after platinum-based chemotherapy, tarlatamab was superior to chemotherapy with respect to median overall survival.
Reference
Giannis Mountzios, Longhua Sun, Byoung Chul Cho et al. Tarlatamab in Small-Cell Lung Cancer after Platinum-Based Chemotherapy. N Engl J Med. 2025 Jun 2. Online ahead of print.
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